Manufacturing Associate – cGMP API Production

Position Overview

You will be a key member of a multidisciplinary manufacturing team supporting the cGMP production of noncommercial clinical API batches. This role is handson and processdriven contributing directly to API development by executing batch operations supporting equipment qualification and ensuring compliance with cGMP and safety standards. Work is performed in a pilotscale manufacturing environment with close collaboration across Quality Compliance and technical teams.

Standard operations involve chemical synthesis of APIs including solid and liquid handling distillation extraction crystallization filtration and drying.

Key Responsibilities

Manufacturing Operations

• Execute Process Operating Instructions and batch records in a regulated cGMP (GxP) environment.
• Prepare operate monitor sample and clean complex pharmaceutical manufacturing equipment according to SOPs.
• Perform handson chemical processing activities including:
  • Solid and liquid charging
  • Atmospheric and vacuum distillation
  • Liquidliquid extractions and phase separations
  • Crystallization filtration milling and drying
• Perform routine manual material handling including lifting and moving loads 50 lbs using proper safety techniques.
• Identify troubleshoot and resolve equipment and process issues.

Documentation & Compliance

• Generate review and execute cGMP documentation such as:
  • Batch records
  • Cleaning records
  • Inprocess control sampling documentation
• Support equipment commissioning and qualification activities.
• Participate in SOP periodic reviews.
• Report deviations observations or safety concerns that may impact product quality or process safety.
• Ensure proper handling segregation and disposal of manufacturing waste in compliance with environmental and safety requirements.

Collaboration & Continuous Improvement

• Communicate effectively across crossfunctional teams including Quality Compliance Process Chemists Analysts and Supervisors.
• Actively participate in shift handovers and operational communications.
• Identify and implement continuous improvement opportunities.
• Prioritize personal workload and support lessexperienced colleagues in task planning and execution.
• Complete required training and participate in facility safety inspections.

Qualifications :

• High School Diploma or GED required
• 4 years of relevant manufacturing experience
• Demonstrated experience in a cGMP pharmaceutical manufacturing environment
• Working knowledge of Production Control Systems
• Strong troubleshooting problemsolving and criticalthinking skills
• Ability to work independently while contributing effectively within a matrix team
• Strong organizational skills attention to detail and followthrough
• Physically capable of:
  • Standing for extended periods
  • Lifting 50 lbs
  • Wearing PPE and working with hazardous materials
• Excellent written and verbal communication skills
• Proficient in Microsoft Office (Word Excel)

Preferred Qualifications

• Associate degree in a scientific or technical discipline
• Strong mechanical aptitude with a handson mindset
• Experience with DeltaV Production Control System
• Experience supporting API manufacturing in a cGMP environment
• Handson experience with largescale distillation filtration drying or milling operations

Additional Information :

• After the initial training period of approximately 3 months which will be Monday- Friday from 8am-5pm team members move to swing shift which alternates between 1st shift and 2nd shift:

  1st Shift is Mon-Fri 6:00 am to 2 pm

  2nd Shift is Mon Thurs 2 pm to 12 pm

• May be requested to work on weekends overtime and holidays based on business needs.
• Candidates currently living within a commutable distance of Groton CT are encouraged to apply.
• Ability to work overtime as required.
• Excellent full-time benefits including comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• #LI-EB1
• Authorization to work in the United States indefinitely without restriction or sponsorship

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time